Kornimate/medical-research-clean huggingface dataset:
use of a liquid supplement containing 2 human milk oligosaccharides (hmos) in preterm infants

Conditions: Premature Infant

Summary: this is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in france, consisting of 2 parallel groups. the experimental group will receive a neonatal supplement containing 2 specific hmos. the control group will receive a placebo neonatal supplement that does not contain any hmos, but matched to the experimental product in energy content. this study will include a total of approximately 86 male and female preterm infants born between 27 and 32 weeks' gestational age with birth weight ≤1700 g, who are younger than 7 days of age. the primary objective of the study is to demonstrate the safety and tolerance of hmos in preterm infants by monitoring weight gain rates in both of the two randomized groups.


Eligibility criteria:
inclusion criteria: * infant's birth weight ≤1700 g. * infant's gestational age ≥ 27 weeks + 0 days and ≤ 32 weeks + 6 days. * infant is clinically stable * infants are eligible to start hmos / placebo as soon as possible after birth, but still within the first 7 days of life. * written informed consent has been obtained from the parents/legally acceptable representative (lar). exclusion criteria: * parents not willing / not able to comply with the requirements of study protocol. * infants receiving ongoing prophylactic antifungal therapies. * infants experiencing early onset sepsis. * major congenital or chromosomal abnormality known to affect growth. * liver failure. * severe intrauterine growth restriction (iugr) as defined by having birth weight less than 2nd percentile on the fenton growth chart. * peri-/intra-ventricular haemorrhage (grade 3-4 in papille classification) . * infant in critical condition needing intubation or inotropic agents for treatment. * infant requiring prolonged (more than 3 doses) of steroid treatment. * infants' participation in another interventional clinical trial that would have significant impact on current study's results. * infants who have already achieved full enteral feeding (fef) prior to enrolment, using the definition accepted by neonatal unit as per standard practice (150 ml/kg/day).
evaluation of clinical features and surgical outcomes of the too long anterior process in children

Conditions: Calcaneonavicular Coalition

Summary: calcaneonavicular coalition represents approximately 1% of the population between 8 and 12 years. they are manifested by repeated ankle sprains or by pain. - the diagnosis is radiological on an x-ray of the foot in oblique-3/4 incidence as well as magnetic resonance imaging. treatment is second-line surgery after failure of orthopedic treatment. this surgery is either by direct approach or by arthroscopy, by performing a bone resection to recreate sufficient space in the joint in question. the patients in this study will only be operated on openly.


Eligibility criteria:
inclusion criteria: * child \<16 years * child with calcaneonavicular coalition * magnetic resonance imaging diagnosis * patient already treated orthopedically in the initial treatment of the coalition exclusion criteria: * child \>=16 years
sub-type specific genomic mutations in sbots

Conditions: Ovarian Neoplasm Epithelial

Summary: the aim of this study is to identify different origin in carcinogenesis between serous borderline ovarian tumors presenting a. without implants, b. with non-invasive implants, c. with invasive implants and d. with micropapillary pattern. the presence of specific mutations could suggest for a more aggressive primary treatment if a higher risk of recurrence can be expected.

introduction borderline ovarian tumors (bots) behave indolently in the vast majority of cases and the prognosis is usually favorable. there is more evidence that two subtypes of bots represent a higher risk of recurrence or even progression to an invasive ovarian cancer. in case of a presentation with a micro-papillary grow pattern or when invasive implants are diagnosed the prognosis tend to be less favorable. genome sequencing in ovarian cancer helped to differentiate two different pathways in the carcinogenesis. low grade serous carcinomas evolving from adenofibromas or borderline tumors over non-invasive micropapillary serous borderline tumors to invasive micropapillary serous carcinoma, show frequent mutations in the kirsten rat sarcoma gene (kras), b-raf kinase gene(braf), erb-b2 receptor tyrosine kinase 2 gene (erbb2), phosphatase and tensin homolog gene (pten), phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (pik3ca) and catenin beta 1 gene (ctnnb1). this pathway is called type i and is characterized by a slow step-wise process. these low-grade invasive tumors are indolent and are known with a better outcome than high-grade invasive tumors. in contrast the type ii pathway development of invasive tumors is rapid and vast majority of tumors show a tumor protein p53 (tp53) mutation and loss of breast cancer type 1 susceptibility protein (brca1). the aim of this study is to identify different origin in carcinogenesis between serous borderline ovarian tumors presenting a. without implants, b. with non-invasive implants, c. with invasive implants and d. with micropapillary pattern. the presence of specific mutations could suggest for a more aggressive primary treatment if a higher risk of recurrence can be expected.

Eligibility criteria:
inclusion criteria: * paraffin embedded material from the original borderline ovarian tumor must be present and of good quality for dna extraction. * original slides are available for central pathological review. exclusion criteria: * presence of invasive ovarian carcinoma.

Keywords: low malignant potential serous
a study of an investigational regimen combining fda approved hiv drugs in hiv-infected subjects

Conditions: HIV Infection; Infection, Human Immunodeficiency Virus

Summary: this is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg qd) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.

a phase iiib, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of lexiva (700mg/100mg bid or 1400mg/200mg qd) to a once-daily, 100mg ritonavir-boosted regimen of lexiva (1400mg/100mg qd)

Eligibility criteria:
inclusion criteria: * subjects with hiv-1 infection. * are willing and able to understand and provide written consent prior to participation in this study. exclusion criteria: * are pregnant or breastfeeding. * have an active aids condition, pancreatitis, poor kidney function, or clinically relevant hepatitis. * have certain medical conditions that may make participation unsafe. * take medication that may interact with the study medication. * have a history of allergy to any of the study drugs or any excipients therein. * other inclusion/exclusion criteria to be evaluated by the physician.

Keywords: hiv-1 lexiva ritonavir once-daily
divalproex vs. lamotrigine for bipolar disorder

Conditions: Bipolar Disorder

Summary: this study is a retrospective chart review of patients treated for bipolar disorder at the tvamc in the past four years cross-referenced with the electronic pharmacy file for having received a prescription of divalproex or lamotrigine.

the primary objective of the study is to assess the long-term outcome in bipolar patients treated with divalproex versus lamotrigine in a retrospective chart review of veterans as measured by time to relapse into any significant mood episode (i.e. mania or depression). the primary hypothesis is that bipolar patients will demonstrate significantly greater time to relapse in those treated with divalproex compared to those treated with lamotrigine. the secondary objective of the study is to assess the safety and relative tolerability of divalproex and lamotrigine in this population based on discontinuation due to side or adverse effect.

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar i or bipolar ii disorder * prescription of divalproex (any formulation except for depakene/valproic acid) or lamotrigine in the electronic pharmacy profile. * age 19 or older * demonstrated stability for at least 4 weeks on an adequate dose of each medication (at least 50mg/d lamotrigine or 15mg/kg/day divalproex). * treatment at the tvamc for at least 6 months following the prescription of divalproex or lamotrigine. exclusion criteria: * primary diagnosis of schizoaffective or schizophrenia during the evaluation period. * prescription of divalproex and lamotrigine given concurrently during the observation period. * history of dementia or cognitive disorders

Keywords: bipolar disorder relapse retrospective
statins evaluation in coronary procedures and revascularization trial

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to determine whether a loading dose of atorvastatin before percutaneous intervention procedures in acute coronary syndromes is effective to reduce major cardiovascular events(mace).

background: strategies to reduce complications in acute coronary syndrome treatment have been largely studied. due to its pleiotropic effects statins are considered an important tool on atherosclerotic plaque stability. although, the usage of statins before percutaneous coronary intervention in acute coronary syndrome patients, has not yet been demonstrated. objectives: evaluate if a loading dose of atorvastatin (80mg) before percutaneous coronary intervention in acute coronary syndrome patients, followed by a reload dose 24 hours, is able to reduce major cardiovascular events (mace); including combined outcomes such as all-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting after 30 days. methods: multicentric randomised controlled clinical trial, with allocation concealment and intention to treat analysis. competitive recruitment will involve 4,192 patients. acute coronary syndrome patients intending to undergo percutaneous coronary intervention with or without stent placement will be randomized 1:1 to receive either atorvastatin 80mg or placebo before the coronary procedure and also a reload dosage after 24 hours from angioplasty. all patients will collect blood sample to determine ckmb levels pre and post procedure (6 to 12h and 18 to 24 hours). after 30 days, an in person interview will be performed and blood sample will be collected in order to dosage ast, alt, cpk, and cholesterol levels. telephonic interview will be done at 6 and 12 months to access occurrence of cardiovascular events.

Eligibility criteria:
inclusion criteria: * acute coronary syndrome patients intending to undergo percutaneous coronary intervention. exclusion criteria: * younger than 18 years * presence of any contraindication to statin (pregnant women, breast-feeding women or statin hypersensibility) * advanced hepatic disease * use of statins at the maximum dosage in the last 24 hours before the loading dose of the study drug * use of fibrate in the last 24 hours
using psychophysics methods to investigate sensory dominance after cataract surgery

Conditions: Cataract

Summary: using psychophysics methods for quantitative assessment of sensory binocular imbalance after cataract surgery

using binocular phase combination paradigms and binocular rivalry paradigms to quantitatively assess the degree of sensory binocular imbalance in patients following cataract surgery, investigating the relationship between unilateral and bilateral cataracts in children and varying severities of cataracts in adults with respect to sensory ocular dominance, and forecasting the postoperative quality of life for patients.

Eligibility criteria:
inclusion criteria: 1. ages between 6 and 90 years old, and the individual or legal guardian is capable of understanding and voluntarily signing an informed consent form; 2. no history of ocular trauma or intraocular surgery, no physical or medical treatments have been undergone, and the clinical diagnosis in the medical records is age-related, congenital, or developmental cataract patients; 3. best-corrected visual acuity in both eyes is greater than 0.8 before the study, fusion ability is normal as checked by worth's 4-dot test, and at least 1 month has passed since the last surgery; 4. good communication skills and the ability to understand and grasp the trial; 5. no significant contraindications to surgery found in preoperative systemic and ocular examinations. exclusion criteria: 1. patients with traumatic or complex cataracts; 2. those diagnosed with glaucoma before or after surgery; 3. individuals with a history of intraocular surgery (such as vitrectomy) or laser treatment; 4. exclude those with severe ocular comorbidities (including microphthalmia, aphakia, anterior segment dysgenesis, uveitis, optic nerve dysplasia, retinopathy of prematurity, congenital glaucoma, etc.) and severe systemic comorbidities (including syndromes affecting connective tissue function, such as marfan syndrome, homocystinuria, or down syndrome, severe birth defects, and epilepsy); 5. any systemic diseases related to the eyes, such as rheumatic immune diseases; 6. those with surgical records indicating any severe intraoperative complications during cataract surgery; 7. individuals who cannot cooperate with the examination.
botulinum toxin injections by ultrasounds guidance and stretching exercise in spastic toe clawing

Conditions: Cerebrovascular Accident

Summary: claw toes deformity result in spasticity often seem in patients with central nerve disease. it also cause pressure sore in foot and pain during walking that didn't well improve under traditional treatment. there are few relative reports about the botulinum toxin type a (btx-a) injection on claw toe. the investigators' study has two main purposes: 1. assess the efficiency of btx-a injection under ultrasonographyic guidance on improving lower extremities function, pain and spasticity in patients with symptomatic claw toes. 2. assess if regular stretching exercise can strength the efficiency of btx-a injection on improving lower extremities function, pain and spasticity.

the investigators will enroll 50 hemiplegic stroke patients met the inclusion criteria(onset more than 6 month, lower extremity brunnstrome stage more than stage iv, walking without assistance devices and pain during walking due to claw toe. the investigators will focus and inject btx-a with ultrasonographyic guidance on flexor digitorum longus and brevis(both 50 unit). if patients combine ankle plantar flexors spasticity, the investigators will inject another 50 unit on both the medial and lateral head of gastrocnemius . every patients will receive regular stretching exercise in hospital and do self stretching exercise at home for 3 months after injection. patients will be evaluated at 2 weeks, 4 weeks and 12 weeks, 24 weeks and 1 year after injection. outcome measure include severity of spasticity and pain, sensory and motor function, range of motion, functional assessment of lower extremity and analyze pressure under foot.

Eligibility criteria:
inclusion criteria: * patient with spasticity toe clawing(metatarsophalange jointextension, proximal and distal phalange joint flexion) * mas scale of metatarsophalange joint and interphalangeal joint more than 2 * pain during walking, abnormal gait patterns and can't wear shoess due to claw toe * haven't received botox or phenol or alcohol injections before exclusion criteria: * lower extremities joint contrature, bone deformity * had received botox injections or phenol injections or before due to lower extremities spasticity * combine other neuromuscular system disease * severe cognition disorder or aphasia after stroke * significant atrophy of flexor digitorum longus and brevis * allergy to botox * infection on injection site * have systemic infection * now accept aminioglycoside or other medicine will affect neuromusclar transition

Keywords: spasticity claw toe ultrasounds guidance botulinum toxin stretching exercise
clinical effect of stellate ganglion block on gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: the goal of this clinical trial is to explore clinical effect of stellate ganglion block on gastroesophageal reflux disease. the main question it aims to answer is: • can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given stellate ganglion block once a day additionally. the study lasts 20 days for each participant. researchers will compare the gastroesophageal reflux disease questionnaire, pressure pain threshold, self-evaluation questionnaire for gastroesophageal reflux disease, to see if the stellate ganglion block can help improve the symptom.

gastroesophageal reflux is a common digestive disorder characterized by the backflow of stomach contents and fluids into the esophagus. the goal of this clinical trial is to explore clinical effect of stellate ganglion block on gastroesophageal reflux disease. the main question it aims to answer is: • can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given stellate ganglion block once a day additionally. the study lasts 20 days for each participant. researchers will compare the gastroesophageal reflux disease questionnaire, pressure pain threshold, self-evaluation questionnaire for gastroesophageal reflux disease, to see if the stellate ganglion block can help improve the symptom.

Eligibility criteria:
inclusion criteria: * gastroesophageal reflux disease diagnosis after determination of acid reflux by gastroenterologist, with upper endoscopy and/or impedance-phmetry, which confirmed esophagitis and/or hiatal hernia. * aged between 18 and 80 years old. * subjects who tolerate cervical movements in sitting position. * stable vital signs. * normal consciousness exclusion criteria: * contraindications for stellate ganglion block. * peptic ulcer. * previous or present gastric cancer. * previous gastric surgery. * recent fractures or cervical trauma.
augmenting patching treatment for amblyopia with physical exercise

Conditions: Amblyopia

Summary: researches are trying to establish whether moderate exercise enhances the treatment benefit of patching 2 hours a day for residual amblyopia in children.


Eligibility criteria:
inclusion criteria: * aged 5 to \< 17 years old * cycloplegic refraction within past year * diagnosis of residual amblyopia, with no evidence of regression of amblyopic eye visual acuity by 1 or more logmar from best previous * completed at least 6 months prior patching treatment (minimum 2 hours/day) or atropine treatment. * stable visual acuity as defined by \<1 logmar change over 2 visits * xbox 360 kinect, wii or wiiu gaming system in the home, or a different gaming system with a version of just dance® already in the home. exclusion criteria: * known problems with exercise tolerance * no gaming system in the home that supports just dance® kids 2014, and no existing version of just dance® in the home * current atropine treatment for amblyopia
developing a screening tool for primary immunodeficiency disease (pid) in pakistan

Conditions: Primary Immunodeficiency Diseases

Summary: case-control diagnostic accuracy study with 130 potential pediatric pid+ (primary immunodeficiency) patients, and 100 age-matched, healthy controls (pid-). the potential pid+ participants will be recruited prospectively through 9 hospitals in sindh and punjab states or contacted via the pid surveillance registry developed by aku hospital's polio excretion in pid study to identify children with primary antibody deficiency (pad+: a type of pid+); healthy, age-matched pid-participants will be recruited by snowball sampling. at the point of care, health care workers (hcws) will collect capillary blood samples (0.1ml) to run the pid rapid screening test and reader on potential pid+ participants (identified by exhibiting \>2 of the jeffrey modell warning signs) and healthy, age-matched controls. all pediatric study participants will be sent to the hospital lab to have a confirmatory immunology panel (see 4.4.1 diagnosing pid for the battery of tests) run on a serum/plasma sample to confirm their pid diagnosis (pid+/pad-, pid+/pad+, pid-); a 1.5ul aliquot of serum/plasma will simultaneously be used to run a pid rapid screening test by a laboratory technician (lt). hcws and lts will be blinded to true pid status. blood and serum pid rapid screening test results will be compared to the confirmatory immunology panel to determine diagnostic accuracy. all clinical management of study participants will follow the standard of care for pid in pakistan and will be based upon the immunology panel result. the hcws and lts administering the tests will be trained prior to the diagnostic accuracy test (see objectives below) and will provide feedback on the tool post-training and post-use to assess usability, acceptability, and feasibility of integrating the test and digital reader into tertiary hospitals for the purpose of improved national pid surveillance, improved pid patient care, and polio eradication in pakistan.


Eligibility criteria:
inclusion criteria: * aged 3 months to 15 years * presents for care at 1 of 9tertiary hospitals participating in the study * potential pid+ (case): child is identified by hcw to have \>2 jeffrey model warning signs of pid. \[note: upon immunology panel testing, this group will be separated into three categories: pid-, pid+, and pid+/pad+ meaning they have 1 of 5 relevant primary antibody deficiencies (pad+)\]. * pid-(control): child is identified (by snowball sampling) as being in good health, and having the same age (within 12 months) as another child who produced a pid+ result. * caregiver consents to participate in the study and provides informed consent. if their children are 10 years of age or older, that child must also give assent. exclusion criteria: * aged less than 3 months or greater than 15 years of age * caregiver does not consent to participate, or child \>10years does not give assent to participate. * having received ivig in the past 90 days